Using Blood Tests to Guide Reduced Radiation Treatment After Surgery for HPV-Positive Throat Cancer

What this Trial Is About

This research focuses on oropharyngeal squamous cell carcinoma OPSCC, a type of throat cancer linked to human papillomavirus HPV infection. The trial evaluates if reducing treatment intensity based on circulating tumor HPV DNA ctHPVDNA levels after surgery can maintain or improve outcomes while lowering treatment side effects. It is a prospective phase II trial aiming to personalize treatment for patients with HPV-positive OPSCC undergoing transoral surgery and neck dissection. Participants will be assigned to different post-surgery treatments guided by their ctHPVDNA test results. Those with undetectable ctHPVDNA and fewer affected lymph nodes will receive no further treatment. Patients with undetectable ctHPVDNA but more extensive nodal involvement or extranodal extension will receive a lower dose of radiation 30 gray. If ctHPVDNA is detectable, patients will undergo reimaging and possibly additional surgery, with treatment adjusted according to repeat ctHPVDNA results and disease status, including higher dose radiation 40 gray if necessary. During the study, participants will be monitored for disease-free survival up to 24 months after surgery, along with local-regional control, overall survival, distant metastasis rates, and adverse events for up to 6 months. Quality of life related to swallowing and gastrostomy tube dependence will also be assessed at multiple time points. The study involves blood tests to measure ctHPVDNA, imaging scans, pathology analysis, and clinical evaluations to guide treatment and assess outcomes with safety monitoring throughout the follow-up period.

ctHPVDNA in HPV Positive Squamous Cell Carcinoma of the Oropharynx